Myth #1: I heard that someone could patent my genes.
FACT: Prior to the Supreme Court ruling of June 13, 2013, Myriad held patents on the BRCA1 and BRCA2 genes themselves, including the genetic sequence, mutations along the genes and any method for locating mutations on the gene. These patents, like other patents, were granted for 20 years. These patents restricted other scientists from any research involving these genes and from others being able to develop or offer alternate testing.
While pharmaceutical, biotechnology and diagnostic companies do invest time and money to develop new medicines and diagnostics, more than five million dollars of federal tax money funded the discovery of the BRCA1 gene specifically. Furthermore, studies have shown that financial incentives are not needed to fuel scientific research in this area. In fact, the Human Genome Project sequenced the entire human genetic sequence and did not patent any of the genes it identified.
Myth #2: I can’t get a second opinion because of gene patents.
FACT: While the presence of a mutation in a BRCA gene or a “positive” test result, could be confirmed by other laboratories, there was no alternative test to confirm a negative test (and the vast majority of patients test negative, meaning no mutations are found in BRCA1 or BRCA2). In fact, for years Myriad provided many patients with “negative” results on their ‘Comprehensive’ BRACAnalysis when they actually harbored harmful BRCA mutations. In 2001, European researchers identified several mutations that Myriad’s test failed to find. An estimated 12% of women received erroneous negative test results on the ‘Comprehensive’ BRACAnalysis when in fact they carried a cancer-predisposing change in one of their BRCA genes. These “false negative” test results have literally cost the lives of women who were under the mistaken impression that they were not at increased risk to develop a deadly cancer. Myriad then waited years before offering their BART testing (for an additional cost of $700) to detect these changes.
Myth #3: Gene patents restrict access to genetic testing.
FACT: Myriad’s claim that 95% of all appropriate patients have access to testing through private insurance is deceptive, as some insurance companies do not consider women without a personal diagnosis of breast or ovarian cancer to be “appropriate” for testing. Women who are at high-risk based on their family histories may not meet insurance criteria for coverage. Their only alternatives are to pay themselves for Myriad’s test, which is prohibitively expensive for many, or forgo testing.
Also, many patients who do not meet insurance criteria are counseled as such before testing, and their DNA is never sent to Myriad. Therefore, Myriad has no idea how many appropriate patients are unable to have the testing they need.
The criteria for Myriad’s financial assistance program are extremely stringent and based on the U.S. Department of Health and Human Services poverty guidelines thereby excluding many women who need the test, live above “poverty” but can not afford the $4000 price tag. Myriad has deemed that the “neediest” of patients, those who are recipients of government funded programs (i.e., Medicaid, Medicare) or those that have any third-party insurance are not eligible to apply for their assistance program.
There are also medical criteria that patients must meet to apply for the financial assistance program and many at-risk women who are not currently affected with cancer would not meet the medical criteria even if they were to be impoverished enough to meet Myriad’s financial criteria. Individuals who can not afford the test but do not meet the criteria for financial assistance have no other options as Myriad has prevented any other option from existing.
Myth #4: Patented products are more expensive.
FACT: The current cost of BRCA1 and BRCA2 testing through Myriad is more $4000. In 1998, when the technology used to perform this test was newer and more expensive, academic laboratories were charging $1600. However, the company owning these genes continued to charge more money for a test that became progressively less expensive to perform. In fact, the cost of the DNA sequencing technology used has plummeted in the past 15 years. In the 1998 documentary film, In the Family, Joanna Rudnick, a BRCA carrier, speaks to Myriad’s owner and asks him directly why the price of the test is increasing when the cost of the technology used is decreasing. “That’s a good question,” he answers. He continues by saying, “I think there’s a point at which we have to start looking at decreasing the costs of the test.” That interview was in 1998, more than 15 years ago. Apparently Myriad does not feel that they have arrived at the “point” to consider decreasing the costs. They haven’t needed to. A complete monopoly means no free market competition.
Myth #5: Gene patents hinder research.
FACT: Not only did Myriad hold the patents on these two genes but also they also aggressively enforced their ownership rights. Myriad sent “cease-and-desist” letters to scientists researching these genes and laboratories who were providing diagnostic tests to their patients. Studies have shown that more than 50% of genetic labs have stopped research due to concerns about patented genes. This is the definition of hindering research.
Gene patents also interfere with research studying the influence of other genes and environmental factors towards the development of disease. Researchers have not been able to study how the BRCA genes may interact with other genes or with outside environmental factors, as that would entail examining the BRCA gene itself, which was prohibited by Myriad.
Aaron S. Kesselheim and Michelle Mello. (2010) Gene Patenting – Is the Pendulum Swinging Back? New England Journal of Medicine 362:1855-58
Ellen Matloff and Arthur Caplan. (2008) Direct to Confusion: Lessons Learned from Marketing BRCA Testing. The American Journal of Bioethics 8(6):5-8
Eric Hoffman. (2011) Why Gene Patents Are Bad for Patients and Science. The-american-interest.com
Robert Dalpe et al., Watching the Race to Find the Breast Cancer Genes. Science, Technology, & Human Values 28(2): 187-216
Ellen Matloff and Karina Brierley. (2010) The double-helix derailed: the story of the BRCA patent. The Lancet 376:314-15
Mildred K. Cho et al., Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services. Journal of Molecular Diagnostics 5(1):3-8
Wetterstrand KA. DNA Sequencing Costs: Data from the NHGRI Large-Scale Genome Sequencing Program Available at http://www.genome.gov/sequencingcosts/.